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Session 6: Making Sound SASS Determinations for CFL Communications
Session Chair(s)
Mark Gaydos
Global Head, Advertising & Promotion, Global Regulatory Affairs
Sanofi, United States
Since the 2018 issuance of FDA’s guidance on Medical Product Communications that are Consistent with FDA-Required Labeling, we have seen a proliferation of this information being included in prescription drug promotion. The new evidentiary standard, scientifically appropriate and statistically sound (or SASS), defined in the guidance is a flexible standard whose robustness varies with the nature of the information being communicated. While this presents opportunities for sponsors to expand on the data and other analyses used in promotion, it also presents challenges in terms of ensuring the supporting evidence is adequate in each instance, not to mention appropriately contextualized with study design limitations and other relevant disclosures. During this session, we will examine approaches to CFL assessment, the characterization of CFL information in promotion, and lessons learned from FDA’s CFL-related enforcement since the guidance was issued.
Learning Objective :
- Describe the SASS standard and the importance of rigorous CFL assessment consistent with the 2018 FDA guidance
- Determine the types of expertise, beyond traditional review committee roles, teams should consider involving in CFL analyses
- Apply learnings from CFL-related FDA enforcement actions that articulate the Agency’s areas of concern and focus
Speaker(s)
Speakers
Mark Gaydos
Sanofi, United States
Global Head, Advertising & Promotion, Global Regulatory Affairs
Speaker
Adam George, PharmD
ANG Regulatory Consulting, United States
President and Founder
Speakers
Kellie B. Combs, JD
Ropes & Gray LLP, United States
Partner
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